Propiolactone (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: IRRIGATION.
Brand Names
- BETAPRONE
Indications and Usage
FLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUCELVAX is approved for use in persons 6 months of age and older. [see Clinical Studies (14)]
Dosage and Administration
For intramuscular use.
Contraindications
Do not administer FLUCELVAX to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)].
Adverse Reactions
Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions. In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported (≥10%) injection-site adverse reactions were tenderness (28%), erythema (26%), induration (17%) and ecchymosis (11%). The most common systemic adverse reactions were irritability (28%), sleepiness (27%), diarrhea (18%) and change of eating habits (17%). In children 4 through 8 years of age who received FLUCELVAX, the most commonly reported (≥10%) local injection-site adverse reactions were pain (29%) and erythema (11%). The most common systemic adverse reaction was fatigue (10%). In children and adolescents 9 through 17 years of age who received FLUCELVAX, the most commonly reported (≥10%) injection-site adverse reactions were pain (34%) and erythema (14%). The most common systemic adverse reactions were myalgia (15%) and headache (14%). In adults 18 through 64 years of age who received FLUCELVAX, the most commonly reported (≥10%) injection-site adverse reactions were pain (28%) and erythema (13%). The most common systemic adverse reactions were headache (16%), fatigue (12%), myalgia (11%) and malaise (10%). In adults 65 years of age and older who received FLUCELVAX the most commonly reported (≥10%) injection-site reaction was erythema (10%). The most common systemic adverse reactions were fatigue (11%), headache (10%) and malaise (10%).
Mechanism of Action
Specific levels of hemagglutination inhibition (HI) antibody titers induced by vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza illness. In some studies, HI antibody titers of ≥ 1:40 have been associated with protection from influenza illness in up to 50% of adults.3,4 Antibody against one influenza virus type or subtype confers little or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more strains in each year’s influenza vaccine.